Intranasal medication delivery device and method of use thereof

ABSTRACT

The intranasal medication delivery device and method of use thereof includes an elongated malleable member arcuately curved or pre-formed in manner complimentary to the anterior wall of a nasal cavity. One particular embodiment provides the elongated and arcuate member to deliver medication through a lumen such that the medication is deposited in a semi-solid state adjacent the anterior aspect of the nasal cavity lateral wall and to the anterior end of the superior, middle, and inferior turbinate. Another particular embodiment provides the elongated and arcuate member to deliver medication as a suppository to a location similar to that of the previous embodiment. The method of delivering the medicine provides depositing the medicine adjacent the anterior end of one of the superior turbinate, middle turbinate, and inferior turbinate. An exemplary medication can be any one of a corticosteroid, an anti-histamine, an immune active mediator, an IgE binding medication, or a decongestant.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the priority to and the benefit of U.S.Provisional Application Ser. No. 61/980,348 filed on Apr. 16, 2014; theentirety of which is hereby incorporated by reference as if fullyrewritten herein.

BACKGROUND

1. Technical Field

The present invention relates generally to the field of medicationdelivery devices. More particularly, the present invention relates tomedical devices for the delivery of intranasal cavity medication.Specifically, the present invention relates to an intranasal medicationdelivery device configured to deliver medication along the anterior walland the anterior aspect of the lateral wall defining the nasal cavity.

2. Background

Allergies, nasal polyposis, and other inflammatory conditions of thenasal passages remain a leading cause of both acute and chronicillnesses the world over. These disorders are difficult for allergiststo treat. The symptoms of these immune hypersensitivity disordersinclude reddening of the eyes, ocular secretions, loss of taste andsmell, nasal congestion, sinusitis, ocular and palatial irritation,sneezing and mucus hypersecretion, amongst others. These symptoms occurfollowing exposure to allergens. The allergens contact nasal tissuesurfaces and irritate biological pathways. This irritation of biologicalpathways causes inflammation, histamine release, and immunomediators.The most common allergens are grass and/or tree pollens, hence, a nasalallergic disorders is most common during the spring and summer months.While these conditions often occur following exposure to airborneirritants, some conditions may occur without identifiable causes, suchas exposure to cold temperatures free of airborne irritants.

One exemplary nasal allergic disorder is rhinoconjunctivitis. Thesymptoms of allergic rhinoconjunctivitis are believed to be dueprimarily to the stimulation of H-1 receptors by histamine, followed byreflexive activation of parasympathetic nerves causing increases innasal secretion and obstruction. Histamine is initially released fromthe tissue mast cells upon sensitization of the mast cells. Thissensitization results when airborne allergens combine with specific IgEantibodies attached to mast cell membranes.

SUMMARY

Issues continue to exist with nasal allergic disorders, their methods oftreatment and their medication delivery devices. The present inventionaddresses these and other issues.

In one aspect, an embodiment may provide an intranasal medicationdelivery device comprising: an elongated member including a proximalsection spaced apart from a distal section, the elongated memberarcuately shaped in a manner complementary to a nasal cavity anteriorwall; and a medication integrally formed in the elongated memberincluding any one of a corticosteroid, an anti-histamine, an immuneactive mediator, an IgE binding medication, or a decongestant.

In another aspect, one embodiment may provide an intranasal medicationdelivery device comprising: a medication including any one of acorticosteroid, an anti-histamine, an immune active mediator, an IgEbinding medication, or a decongestant; an elongated member including aproximal end and a distal end, the elongated member arcuately shapedbetween the proximal and distal end in a manner complementary to a nasalcavity anterior wall; and a lumen defined by the elongated member toallow the medication to move therethrough.

In another aspect, one embodiment may provide an intranasal treatmentmethod: providing a medicine, the medicine including an any one of acorticosteroid, an anti-histamine, an immune active mediator, an IgEbinding medication, or a decongestant; providing nasal tissues withinthe nasal cavity of a patient, the nasal tissues including a superiorturbinate, a middle turbinate, and an inferior turbinate, each of theturbinate extending anteroposteriorly; and depositing the medicineadjacent the anterior end of one of the superior turbinate, middleturbinate, and inferior turbinate.

In another aspect, an embodiment may provide an intranasal medicationdelivery device and method thereof. The intranasal medication deliveryincludes an elongated member arcuately curved in manner complimentary tothe anterior wall of a nasal cavity. One particular feature provides theelongated and arcuate member to deliver medication through a lumen suchthat the medication is deposited in a semi-solid state adjacent theanterior end of the superior, middle, and inferior turbinate. Anotherparticular feature provides the elongated and arcuate member to delivermedication as a suppository to a location similar to that of theprevious embodiment. The method of delivering the medicine providesdepositing the medicine adjacent the anterior end of one of the superiorturbinate, middle turbinate, and inferior turbinate. The preferredmedication active ingredient is a corticosteroid.

Another aspect provides an intranasal medication delivery devicecomprising: an elongated member including a proximal section spacedapart from a distal section, the elongated member adapted to be disposedin an arcuate manner complementary to a nasal cavity anterior wall; anda medication integrally formed in the elongated member including atleast one of a corticosteroid, an anti-histamine, an immune activemediator, an IgE binding medication, and a decongestant.

Yet another aspect provides an intranasal medication delivery devicecomprising: a catheter defining a lumen operatively connected to amedication container; a medication housed within the medicationcontainer, the medication including at least one of a corticosteroid, ananti-histamine, an immune active mediator, an IgE binding medication,and a decongestant, wherein the medication moves through the lumenduring medication delivery; and the medication, when delivered to ananterior wall of a nasal cavity through the catheter forms an intranasaldeposited elongated member including a proximal end and a distal end,the elongated member arcuately shaped between the proximal and distalend in a manner complementary to the anterior wall.

Yet another aspect provides, a method comprising the steps of:

delivering medicine in a targeted manner to a position within a nasalcavity, wherein the medicine is carried by one of the following:

-   -   (i) a semi-solid base substance within a medication container        configured to be ejected through a lumen;    -   (ii) a self-supporting generally rigid arcuate structure curved        complementary to a curvature of a nasal cavity anterior wall;        and    -   (iii) a semi-flexible linear member including a plurality of        helically extending edges winding about a longitudinal axis; and

wherein the medicine is delivered in a first phase state at a firstviscosity, and then the medicine heats up when exposed to bodytemperature within the nasal cavity and transitions into a second phasestate at a second viscosity lower than the first viscosity such that themedicine flows to coat at least a portion of a turbinate.

BRIEF DESCRIPTION OF THE DRAWINGS

A sample embodiment of the invention is set forth in the followingdescription, is shown in the drawings, and is particularly anddistinctly pointed out and set forth in the appended claims. Theaccompanying drawings, which are incorporated in and constitute a partof the specification, illustrate various examples, example methods, andother example embodiments of various aspects of the invention. It willbe appreciated that the illustrated element boundaries (e.g., boxes,groups of boxes, or other shapes) in the figures represent one exampleof the boundaries. One of ordinary skill in the art will appreciate thatin some examples one element may be designed as multiple elements orthat multiple elements may be designed as one element. In some examples,an element shown as an internal component of another element may beimplemented as an external component and vice versa. Furthermore,elements may not be drawn to scale.

FIG. 1 is a front schematic view of anatomical tissue structuresincluding the maxillary, ethmoid, and frontal sinuses;

FIG. 2 is cross section taken along line 2-2 in FIG. 1 depicting theanatomical tissue structures contained in the nasal cavity;

FIG. 3 is a side view of a nasal medication delivery device;

FIG. 4 is a cross section taken along line 4-4 in FIG. 3 depicting amedication composition loaded into a container portion of a syringeforming a portion of the delivery device;

FIG. 5 is an operational cross section view of the nasal medicationdelivery device in an inserted position in the nasal cavity;

FIG. 6 is an operational cross section view of the nasal medicationdelivery device simultaneously depositing medication into the nasalcavity as the device is drawn outward from the nasal cavity;

FIG. 7 is an operational cross section view of medication depositedwithin the nasal cavity after the device has been fully extracted;

FIG. 8A is an operational cross section view of medication beginning toliquefy and coating a turbinate in the nasal cavity;

FIG. 8B is an operational cross section view of liquefied medicationcoating the turbinate and flowing towards ostea in the nasal cavity;

FIG. 9 is a side view of an alternative embodiment of the medicationdelivery device;

FIG. 10 is a cross section view depicting the alternative embodiment ofthe device inserted into the nasal cavity;

FIG. 11 is a side view of another alternative embodiment of themedication deliver device; and

FIG. 12 is a cross section of the embodiment of FIG. 11 inserted intothe nasal cavity.

Similar numbers refer to similar parts throughout the drawings.

DETAILED DESCRIPTION

As shown generally in FIG. 1 and FIG. 2 and common to human anatomy, aperson 10 has four pairs of sinuses mirrored along the medial plane,namely, a pair of frontal sinuses 12, a pair of ethmoid sinuses 14, apair of maxillary sinuses 16, and a pair of sphenoid sinuses (locatedmore toward the back of the head than the other sinuses and not shown inFIG. 1). Normally, sinuses are filled with air, but when sinuses becomeblocked and filled with fluid, pathogens can grow and cause aninfection. A nasal cavity 18 is a void within the head of person 10configured to permit air to flow therethrough during the respirationprocess. The nasal cavity 18 shown in cross section of FIG. 2 is one oftwo nasal cavities contained in the face. Each left and right nasalcavity is mirroredly positioned opposite the other respective nasalcavity along the medial plane. For the purposes of this disclosure, itis to be understood that all anatomical structures referred to hereinapply similarly to the opposite naval cavity. The nasal cavity 18depicted in FIG. 2 is the left lateral nasal cavity 18.

Nasal cavity 18 is defined by an anterior wall 20 spaced apart from aposterior wall 22 defining an anteroposterior (front-to-back) directiontherebetween. Nasal cavity 18 is defined by a (left) lateral wall 24spaced apart from a medial cartilage (not shown, but lies along crosssection line 2-2 in FIG. 1) defining a lateral (left-to-right) directiontherebetween. Further, nasal cavity 18 is defined by a top wall 26spaced apart from a floor wall 28 defining a vertical directiontherebetween.

A superior turbinate 30, a middle turbinate 32, and an inferiorturbinate 34 are positioned in nasal cavity 18. The term “turbinate”referred to herein also may medically be known as concha. Superiorturbinate 30 is positioned adjacently below the top 26 and is attachedto lateral wall 24. Superior turbinate 30 extends laterally inward inthe medial direction from lateral wall 24 and spirals or winds aboutitself. Superior turbinate extends in anteroposterior direction. Middleturbinate 32 is positioned adjacent the vertical center of nasal cavity18 beneath superior turbinate 30. Middle turbinate 32 is attached tolateral wall 24 and extends anteroposteriorly. Middle turbinate 32extends laterally in the medial direction from lateral wall 24 andspirals or winds about itself as one having ordinarily skill in the artwould understand. Inferior turbinate 34 is positioned adjacently abovethe floor 28 of nasal cavity 18 beneath middle turbinate 32. Inferiorturbinate is attached to the lateral wall 24 and extendsanteroposteriorly. Inferior turbinate 34 extends laterally in the medialdirection from lateral wall and winds about itself.

A first passageway 36 is defined between the bottom side of superiorturbinate 30 and the top side of the middle turbinate 32. A secondpassageway 38 is defined between the bottom side of middle turbinate 32and the top side of inferior turbinate 34. A third passageway 40 isdefined between the bottom side of inferior turbinate 34 and the floor28 of nasal cavity 18. Passageways 36, 38, 40 are open and void spacespermitting air to flow therethrough.

A plurality of ostea 42 (also referred to as ostium 42), are formed inthe lateral wall 24. Ostium 42 permit fluid communication of mucousflowing from the sinus cavities 12, 14, 16 into the nasal cavity 18.

With reference to FIG. 3, one embodiment of a medication delivery deviceis depicted generally as 50. Medication delivery device 50 comprises aproximal end 52 spaced apart from a distal end 54 defining alongitudinal direction therebetween, and comprises a medicationcontainer 56, a catheter 58 in communication with the medicationcontainer 56, and a distal exit port 60. In one particular embodiment,device 50 is an intranasal medication delivery apparatus.

Medication container 56 is defined by an annular or cylindrical sidewall62. A plunger 64 includes two ends, a first end defining the proximalend 52 of device 50 and a second end shaped complementary to an innerannular wall of container 56. Plunger 64 is positioned within container56 and configured to travel longitudinally in a linear manner todecrease the volume of container 56. Plunger 64 is further configured inmanner similar to a conventional syringe and may include components suchas gaskets, seals, and a thumb press.

Catheter 58 on device 50 is an elongated member including a proximal endand a distal end. In a particular embodiment, catheter 58 can beflexible or malleable tubing. In another particular embodiment, catheter58 may be pre-formed at a desired curvature. Catheter 58 is coupled toannular wall 62 adjacent the proximal end and extends longitudinallytowards the distal end 54. Catheter 58 formed in arcuate manner. Thearcuate curve of catheter 58 is shaped complementary to the anteriorwall 20 of nasal cavity 18. Catheter 58 defines a lumen 66 extendingarcuately and longitudinally through the center of catheter 58. Lumen 66extends from container 56 and terminates adjacent distal end 54 definingexit port 60. Lumen 66 is in fluid communication with medicationcontainer 56 and is configured to permit medication 70 to flowtherethrough.

Medication 70 is a composition positioned within container 56 andincludes an effective ingredient 72 and a base substance 74, namely byway of non-limiting example a gelling base. Effective ingredient 72 iscontemplated to treat or deactivate excessive inflammation, suppresshistamine production, or mediator generated symptoms. By way ofnon-limiting example, effective ingredient 72 can include any one of acorticosteroid, an anti-histamine, an immune active mediator, an IgEbinding medication, or a decongestant. For the purposes of thisdisclosure, effective ingredient 72 is also referred to ascorticosteroid 72. Corticosteriod 72 is a chemical that includescorticosteroid hormones synthesized in laboratories including analoguesof naturally produced cortisol hormones. More specifically, in oneparticular embodiment corticosteroid 72 is prednisone or cortisone.Medication 70 may further comprise a small amount of mint-based oil toprovide a pleasing smell to person 10. Additionally, medication 70 mayinclude at least one of ibuprofen, naproxen, paracetamol (commerciallyknown as acetaminophen), oxycodone/paracetamol (commercially known asPercocet or endocet), hydrocodone/paracetamol (commercially known asLortab, Norco, or Vicodin), hydrocodone/ibuprofen (commercially known asViocprofen), oxycodone/aspirin (commercially known as Percodan),oxycodone/naloxone (commercially known as Targin, Targiniq, andTarinact), morphine/naltrexone (commercially known as Embeda), andfentanyl/fluanisone (Hypnorm).

In one particular embodiment, base 74 is a gelled (semi-solid) form ofan anesthetic such as procaine, lidocaine, or novocaine. One exemplarynon-limiting base is a prescription only lidocaine hydrochloride JellyUSP, 2%. Lidocaine HCl Jelly 2% (base 74) is a sterile, aqueous solutionof lidocaine hydrochloride, hypermellose, methyl and propylparaben,sodium hydroxide and/or hydrochloric acid to adjust pH between 6.0 and7.0. Base 74 possess a melting point in the approximate non-limitingtemperature range of about 80 to about 90 degrees Fahrenheit. Once base74 has melted, in one particular embodiment, medication 70 coats theturbinate and lateral wall of the nasal cavity 18, and then can beabsorbed through the mucous membranes within nasal cavity 18 into thebloodstream.

As shown in FIG. 7, after medication 70 has been delivered to the nasalcavity (the medication delivery process described infra), medication 70includes a first amount 76 of medication 70 deposited on and closelyadjacent the top of anterior wall 20, and deposited adjacent theanterior side of top wall 26, and deposited adjacent the anteriorsection of lateral wall 24, and deposited adjacent anterior end ofsuperior turbinate 30.

Medication 70 further includes a second amount 78 of medication 70deposited on and closely adjacent the middle of anterior wall 20, anddeposited below the anterior end of top wall 26, and deposited adjacentthe middle anterior section of lateral wall 24, and deposited adjacentanterior end of middle turbinate 32.

Even further, medication 70 includes a third amount 80 of medication 70deposited on and closely adjacent the bottom (towards the nostril 19) ofanterior wall 20, and deposited below the anterior end of top wall 26,and deposited adjacent the lower anterior section of lateral wall 24,and deposited adjacent anterior end of inferior turbinate 34.

As shown in FIG. 9 and FIG. 10, an alternate embodiment of a medicationdelivery device is depicted generally as 150. Device 150 is anintranasal medicine delivery device comprising a generally rigidelongated member arcuately curved continuously and in a mannercomplementary to a nasal cavity anterior wall 20, a distal section 152on the elongated member, a middle section 154 on the elongated member, aproximal section 156 on the elongated member, and a corticosteroid 72integrally formed in the elongated member of device 150. Device 150 isshown individually stored within a tamper proof package 160 (FIG. 9).

Device 150 is a suppository. As a suppository, device 150 is configuredto dissolve slowly over a set period of time when deposited within ahuman cavity, specifically the nasal cavity 18. The nasal suppository150 comprises a mixture of medication 70 and other substances ordinarilyin suppositories to possess a melting point in the approximatenon-limiting temperature range of about 80 to about 90 degreesFahrenheit. Once melted, in one particular embodiment, medication 70coats the turbinate and nasal cavity surface and then can be absorbedthrough the mucous membranes within nasal cavity 18 into thebloodstream. Suppository 150 is a solid state at room temperature. Thispermits stable handling by the user for placement into the nasal cavity18 through the nostril 19. In a particular example, suppository 150 maybe directly inserted into nasal cavity 18 by the user, not a medicalprovider; however clearly, insertion by medical provider is contemplatedand preferred.

Suppository 150 can be configured in a variety of non-limitingdiameters, lengths, and curvatures to accommodate patients of differentsizes and to permit choice by the user based on an assessment of nasalanatomy and medical needs of the recipient/patient,

Nasal suppository 150 can be made from a greasy base 74, such as cocoabutter, in which the active ingredient (corticosteroid 72) is dissolved;this grease will melt at body temperature. Alternatively, by way ofnon-limiting example nasal suppository 150 can be made from a watersoluble base 74, such as polyethylene glycol, or nasal suppository 150can be made from glycerin base 74 which comprises glycerol and gelatin.

When suppository 150 is deposited in the nasal cavity 18, distal section152 of suppository 150, including medication 70, is deposited on andclosely adjacent the top of anterior wall 20, and deposited adjacent theanterior side of top wall 26, and deposited adjacent the anteriorsection of lateral wall 24, and deposited adjacent anterior end ofsuperior turbinate 30.

Middle section 154 of suppository 150, including medication 70, isdeposited on and closely adjacent the middle of anterior wall 20, anddeposited below the anterior end of top wall 26, and deposited adjacentthe middle anterior section of lateral wall 24, and deposited adjacentanterior end of middle turbinate 32.

Proximal section 156 of suppository 150, including medication 70, isdeposited on and closely adjacent the bottom (towards the nostril 19) ofanterior wall 20, and deposited below the anterior end of top wall 26,and deposited adjacent the lower anterior section of lateral wall 24,and deposited adjacent anterior end of inferior turbinate 34.

As depicted in FIG. 11 and FIG. 12, device 150A is a suppositoryincluding an active ingredient of medication 70 similar to device 150.Device 150A is generally an elongated member and includes a proximal end170 spaced apart from a distal end 172, and a middle section 174therebetween. Device 150A further includes a semi-flexible body 176 onthe device 150A extending between the proximal end 170 and the distalend 172. Device 150A is generally linear in an undelivered positionoutside the nasal cavity 18 (FIG. 11), and device 150A is arcuate in adelivered position inside the nasal cavity 18 (FIG. 12), wherein thesemi-flexible body is configured to arcuately bend during insertion intothe naval cavity.

The term generally linear with respect to device 150A refers to astraight line being able to be drawn along a longitudinal axis of 150Abetween proximal end 170 and distal end 172. However, as is clearlyshown in FIG. 11, body 176 may helically extend and wind around thelongitudinal axis between end 170 and end 172. Namely, helicallyextending edge 178 on the body 176 extends from adjacent the proximalend 170 to adjacent the distal end 172 spiraling or winding around thelongitudinal axis forming a linear corkscrew configuration of body 176.

The diameter associated with body 176 may be uniform from proximal end170 to distal end 172 and may be in a range from about 0.1 mm to about15 mm, and more particularly be in a range from about 1 mm to about 10mm. Alternatively, the body 176 may slightly taper between proximal end170 and distal end 172 effecting a diameter at proximal end 170 greaterthan a diameter at distal end 172.

As depicted by the dashed-lines in FIG. 11, device 150A may flexslightly in the direction of Arrow(s) F. The flexion of device 150Apermits the generally linear configuration in an undelivered positionoutside the nasal cavity 18 (FIG. 11), and the arcuate configuration ofdevice 150A in a delivered position inside the nasal cavity 18 (FIG.12). Additionally in another particular embodiment, corkscrew-like body176 of device 150A may linearly compress and expand along thelongitudinal axis of device 150A. The linear compression and expansionacts slightly similar to a spring allowing portions of device 150A toflexibly move in the longitudinal direction within the nasal cavity 18prior to melting.

In one particular embodiment, corkscrew-like body 176 of device 150A maywind helically a number of revolution(s) about the longitudinal axis perlinear inch. More particularly, device 150A may wind in a range fromabout 0.25 revolutions per linear inch to about 5 revolutions per linearinch. In another particular embodiment, device 150A may wind 1revolution per linear inch.

Device 150A may further include a plug carried 180 by the device 150Aadjacent the proximal end 152, wherein the plug shaped to nest withinnostril 19 via an interference fit. Plug 180 may have a frustoconicalconfiguration including tapered sidewalls. Plug 180 may have a firstdiameter positioned within the nasal cavity 18 past the nostril 19 and asecond diameter outside the nasal cavity and in front of the nostril 19wherein the second diameter is larger than the first diameter such thatthe nostril 19 engages the sidewall of plug 180 via an interference fit.Plug 180 may be formed of any suitable medically safe material, such asrubber, latex, cotton, or the like, to effectively block the nostrilallowing heat to build and increase within the nasal cavity.Alternatively, plug 180 may be formed from a cotton ball connected todevice 150A. Additionally, while plug 180 is shown attached to device150A, clearly, plug 180 could be attached to device 150 as well.

As depicted in FIG. 12, when suppository 150A is deposited in the nasalcavity 18, distal end 172 of suppository 150A, including medication 70,is deposited on and closely adjacent the top of anterior wall 20, anddeposited adjacent the anterior side of top wall 26, and depositedadjacent the anterior section of lateral wall 24, and deposited adjacentanterior end of superior turbinate 30.

Middle section 174 of suppository 150A, including medication 70, isdeposited on and closely adjacent the middle of anterior wall 20, anddeposited below the anterior end of top wall 26, and deposited adjacentthe middle anterior section of lateral wall 24, and deposited adjacentanterior end of middle turbinate 32.

Proximal end 170 of suppository 150A, including medication 70, isdeposited on and closely adjacent the bottom (towards the nostril 19) ofanterior wall 20, and deposited below the anterior end of top wall 26,and deposited adjacent the lower anterior section of lateral wall 24,and deposited adjacent anterior end of inferior turbinate 34.

In accordance with an aspect of one embodiment, device 50, 150, or 150Aallows for precise delivery of medication within the nasal cavity. Thedevice allows an operator (Le., a doctor) to precisely apply medicine tothe anterior ends of the superior, middle, and inferior turbinate. Whilea patient is in the supine position, medicine 70 melts or otherwiseliquefies to coat the turbinate and the edges of the ostium 42. In oneparticular embodiment, device 50, 150, or 150A improves the ability ofthe purposefully deliver medication to a targeted or deliberate area(i.e., a starting point) such that the medication 70 traverses theanteroposterior length of the turbinate by coating a majority of thesurface, rather than conventional sprays which merely mist a bottom andpartial region of the nasal cavity and are more affected by gravity dueto the lower (i.e., less than) viscosity of a liquid than a semi-solid.This feature is a significant non-limiting advantage medication deliverydevice 50, 150, or 150A over conventional nasal sprays, or even salineflushes.

In accordance with another aspect of the present medication deliverydevice is that device 50, 150, or 150A provides medication 70 to thesystemic circulation of the body. This provides a comprehensive coatingof a medicated mixture 70 in a manner other than a conventional nasalspray, which only delivers medication adjacent the nostril 19. Thedelivery of medication 70 is along the entire vertical length of theanterior wall 20, and the anterior end of the lateral wall 24, to treata condition of the nasal turbinate 30, 32, and 34.

In accordance with another aspect of an embodiment of the medicationdeliver device is that device 50, 150, or 150A may reduce pain andbleeding ordinarily associated with nasal instrumentation or nasalcavity device insertion. Further, device 50, 150, or 150A provides acontrolled administration of medication 70 selectively to each of theturbinate 30, 32, and 34.

In operation, intranasal delivery device 50, 150, or 150A is configuredto be inserted into the nasal cavity 18 through a nostril 19. Further inone particular embodiment, device 50, 150, 150A is inserted into thenasal cavity with the patient in the supine position.

As shown in FIG. 5, a cross section of a supine patient details thedistal end 54 breaching nostril 19 and moving into the nasal cavity 18along and following the curvature of anterior wall 20 in the directionof Arrow A. Distal end 54 first passes inferior turbinate 34 betweenturbinate's 34 anterior end and the anterior wall 20 of the nasal cavity18. Distal end 54 continues moving in the direction of arrow A followingthe curvature of anterior wall 20 and passes the middle turbinate 32between turbinate's 32 anterior end and the anterior wall 20 of nasalcavity 18. Distal end 54 continues moving in the direction of arrow Afollowing the curvature of anterior wall 20 and passes the superiorturbinate 30 between turbinate's 30 anterior end and the anterior wall20 of nasal cavity 18.

Distal end 54 comes to rest adjacent the top of anterior wall 20,adjacent the anterior end of top wall 26, adjacent the anterior sectionof lateral wall 24, and adjacent the anterior end of superior turbinate30. This is considered the inserted position. When in the insertedposition, the catheter body 58 is positioned adjacent the anterior wall20 of nasal cavity in an arcuate manner complementary to that ofanterior wall 20. With continued reference to the inserted position, thedistal end 54 is adjacent the superior turbinate 30, a middle section ofcatheter 58 is adjacent the middle turbinate 32, and a proximal sectionof catheter 58 is adjacent the inferior turbinate 34.

As depicted in FIG. 6, a medication delivery process occurssimultaneously with the device 50 extraction process. In one particularembodiment, a medical provider simultaneously performs the medicationdelivery process and the device extraction process. With reference toFIG. 5 through FIG. 7, once the device 50 is considered to be in theinserted position (FIG. 5), device 50 is then ready to be extracted anddeliver the medication (FIG. 6 and FIG. 7).

The medical provider stabilizes medication container 56. By way ofnon-limiting example container 56 may be stabilized by securingcontainer 56 between two fingers of the medical provider. Plunger 64 isthen moved in the direction of Arrow B. Arrow B is generally in thedirection of towards the patients face. In one particular embodiment,plunger 64 is moved by the thumb of the medical provider. By movingplunger 64 in the direction of Arrow B, plunger contacts medication 70stored within container 56. As movement of plunger 64 continues,medication 70 moves from container 56 through lumen 66 and eventuallyexits out through distal exit port 60. Medication 70 moves generally inthe longitudinal direction. Once exiting port 60, a first portion ofdeposited medicine 70 is adjacent the top of anterior wall 20, adjacentthe anterior end of top wall 26, adjacent the anterior section oflateral wall 24, and adjacent anterior end of superior turbinate 30. Inthis particular non-limiting embodiment, the gelled medication 70 is anon-Newtonian fluid and the gel consistency of medication 70 permits itto stay in that position a short period of time prior to liquefying (thestep of liquefying described infra).

Device 50 is extracted from nasal cavity 18 through nostril 19 in thedirection of Arrow C. During this extraction movement, medical providercontinues to move plunger 64 in the direction of Arrow B. This causesmedication 70 to be deposited in a targeted manner adjacent the anteriorend of turbinate 32, 34 as device 50 is drawn or extracted outwardlyfrom the nasal cavity 18.

As shown in FIG. 7, once device 50 has been completely extracted,medication 70 is considered to be deposited in a targeted starting areaof the nasal cavity 18. In this targeted deposition position, the firstamount 76 of medication 70 is adjacent the anterior end of superiorturbinate 30 and adjacent the anterior aspect of lateral wall 24. Thesecond amount 78 of medication 70 is adjacent the anterior end of middleturbinate 32 and the anterior aspect of lateral wall 24. The thirdamount 80 of medication 70 is adjacent the anterior end of inferiorturbinate 34 and the anterior aspect of lateral wall 24. Further, inthis deposited position, medication 70 is in a first phase state at afirst viscosity. The first phase state of medication 70 may be a solid(i.e., suppository 150, or 150A) or a semi-solid (gel delivered bydevice 50). It is noteworthy that unlike known nasal-sprays, in oneparticular embodiment, the medication delivery device 50, 150, and 150Ais preferably not in liquid form at the delivery stage (like a nasalspray), although it could be. It is only once the medication 70 has beenprecisely delivered in its solid or semi-solid state will it then turnto liquid.

After device 50 (or 150, 150A) has delivered the targeted deposition ofmedication 70, the nostril 19 of the patient is plugged with a cottonball (or plug 180) or some other equivalent gauze. The plugging ofnostril 19 causes heat to build up within the nasal cavity. Increasingthe temperature in this manner assists in speeding up the liquefyingprocess of medication 70 from its first solid or semi-solid state to thesecond liquid state.

With reference to the operation depicted in FIG. 8A and FIG. 8B,medication 70 liquefies or melts at a transition temperature (i.e., amelting point). Normally, when exposed to normal body temperature, thetransition temperature will be around 98° F. However, device 50, 150, or150A may be configured to liquefy at other temperatures, such as anytransition temperature between 85° F. and 110° F. The melting causesmedication 70 to transition from a first phase state (solid; orsemi-solid) to a second phase state (generally liquid), wherein thesecond phase state has a viscosity lower (i.e., less than) than that ofthe first phase state. Medication 70 begins to flow posteriorly(downward when the patient is in the supine position). Medication 70moves or flows in a liquid state or semi-solid state having a lowersecond viscosity in the direction of Arrow D. Medication 70 flows viagravity (in the direction of Arrow(s) D) through each of the firstpassageway 36, the second passageway 38, and third passageway 40. Asdepicted in FIG. 8B, medication 70 also moves over each of the superior,middle, and inferior turbinate 30, 32, 34, respectively, to coat eachturbinate. Medication flows into and through ostium 42. In oneembodiment, medication 70 deposited from device 50 is a non-Newtonianfluid at the step of depositing the medicine. Then, medication 70transitions from a non-Newtonian fluid to a Newtonian fluid adjacent theanterior end of one of the first, second, and third passageways.

When medication 70 has melted and is in the liquid state or lowerviscosity state, the active ingredients, namely corticosteroid 72, maybe absorbed into the blood stream. Alternatively, corticosteroid maytopically treat the turbinate 30, 32, 34 and ostium 42 locally.Additional active ingredients (i.e., pain reducers) may also be absorbedby the body as well.

In operation and with reference to FIG. 9 and FIG. 10, suppositorymedication delivery device 150 is unwrapped from its individually sealedpackage 160. Once unwrapped, device 150 is inserted through nostril 19and moving into the nasal cavity 18 in the direction of Arrow Efollowing the curvature of anterior wall 20. In FIG. 10, device 150 isshown by way of non-limiting example being inserted utilizing a forceps162, however clearly manual insertion is entirely possible. Distal end152 (also referred to as distal section 152) of suppository 150 firstpasses inferior turbinate 34 between turbinate's 34 anterior end and theanterior wall 20 of the nasal cavity 18. Distal end 152 of suppository150 continues moving in the direction of arrow E following the curvatureof anterior wall 20 and passes the middle turbinate 32 betweenturbinate's 32 anterior end and the anterior wall 20 of nasal cavity 18.Distal end 152 of suppository continues moving in the direction of ArrowE following the curvature of anterior wall 20 and passes the superiorturbinate 30 between turbinate's 30 anterior end and the anterior wall20 of nasal cavity 18.

Once nasal suppository is in the inserted position (FIG. 10), the distalsection 152 is positioned closely adjacent the anterior end of superiorturbinate 30, the middle section 154 is positioned closely adjacent theanterior end of middle turbinate 32, and the proximal section 156 ispositioned closely adjacent anterior end of inferior turbinate 34.Suppository 150 then begins to liquefy or melt in a similar manner asmedicine 70 delivered by device 50 detailed above.

In operation and with reference to FIG. 12, suppository medicationdelivery device 150A is unwrapped or removed from a packaging. Device150A may be individually packaged, similar to device 150 in packaging160, or alternatively it may provided in bulk packaging. Once unwrapped,device 150A is inserted through nostril 19 in a linear form and is movedinto the nasal cavity 18. Device 150A flexes in the direction of Arrow Fand follows the curvature of anterior wall 20. Distal end 172 ofsuppository device 150A first passes inferior turbinate 34 betweenturbinate's 34 anterior end and the anterior wall 20 of the nasal cavity18. Distal end 172 of suppository 150A continues moving deeper into thenasal cavity following the curvature of anterior wall 20 and passes themiddle turbinate 32 between turbinate's 32 anterior end and the anteriorwall 20 of nasal cavity 18. Distal end 172 of suppository device 150Acontinues moving deeper into the nasal cavity following the curvature ofanterior wall 20 and passes the superior turbinate 30 betweenturbinate's 30 anterior end and the anterior wall 20 of nasal cavity 18.

Once nasal suppository 150A is in the inserted position (FIG. 12), thedistal end 172 is positioned closely adjacent the anterior end ofsuperior turbinate 30, the middle section 174 is positioned closelyadjacent the anterior end of middle turbinate 32, and the proximal end170 is positioned closely adjacent anterior end of inferior turbinate34. Plug 180 fits within nostril 19 sealing heat within nasal cavity 18.As heat begins to rise, suppository 150A then begins to liquefy or meltin a similar manner as medicine 70 delivered by device 50 or device 150detailed above and flows as depicted in FIG. 8A and FIG. 8B.

Further, with respect to the insertion of device 150A, helically windingbody 176 may rotate about its longitudinal axis during the insertion.The number of revolutions of body 176 dictate the number of times device150A revolves within the nasal cavity as device 150A moves deeper intothe nasal cavity.

In operation and with primary reference to the making of medication 70,a first amount of corticosteroid 72 is obtained. In this particularnon-limiting example, reference is made to corticosteroid 72 asprednisone. Prednisone exhibits anti-inflammatory and immunosuppressantproperties when it is converted to prednisolone in the liver. Prednisone72 is available by prescription and ordinarily comes in 1 mg, 2.5 mg, 5mg, and 20 mg tablets.

For an average adult, the medication deliver process described aboveordinarily utilizes 40 mg of prednisone 72. Two 20 mg tablets ofprednisone 72 are pulverized in a mixing dish. The pulverized prednisone72 is then mixed with gelling base 74 to form the composition ofmedication 70. The amount of base 74 is usually in the amount of about 1to 2 cc/ml, preferably about 1.5 cc/ml. The composition medication 70 isthen moved into container 56 so it may be administered to the patient.

In addition to one or more of corticosteroid 72, an antihistamine, animmune active mediator, an IgE binding medication, and a decongestant,medication 70 may also be fabricated with an effective amount ofpeppermint oil, or similar substitute to homeopathically alleviate nasalsymptoms. Medication 70 may also be fabricated with an effective amountof pain-reducing formula. Some exemplary pain reducers areoxycodone/paracetamol, hydrocodone/paracetamol, hydrocodone/ibuprofen,oxycodone/aspirin, oxycodone/naloxone, morphine/naltrexone, andfentanylfluanisone.

An alternatively contemplated nonlimiting example may permit device 50,150 or 150A to selectively administer medication to an anterior end ofany one or two selected turbinate. In one particular embodiment, theremay be an instance where it is not desirable to deliver medication allthe way to the anterior end of the superior turbinate 30. Thus, device50, 150 or 150A can be inserted into the nasal cavity 18 to administermedication to only the middle and inferior turbinate 32, 34,respectively. Or alternatively, medication 70 could be delivered only tothe anterior end of inferior turbinate 32. Or alternatively, medication70 could be delivered only to the anterior end of the superior turbinate30 if the case desired.

In the foregoing description, certain terms have been used for brevity,clearness, and understanding. No unnecessary limitations are to beimplied therefrom beyond the requirement of the prior art because suchterms are used for descriptive purposes and are intended to be broadlyconstrued.

What is claimed:
 1. An intranasal treatment method for nasal tissueswithin a nasal cavity of a patient, the nasal tissues including asuperior turbinate, a middle turbinate, and an inferior turbinate, eachturbinate extending anteroposteriorly, comprising the steps of:providing a medicine, the medicine including an amount of any one of acorticosteroid, an antihistamine, an immune active mediator, an IgEbinding medication, and a decongestant; and depositing the medicineadjacent one of the superior turbinate, middle turbinate, and inferiorturbinate.
 2. The method of claim 1, further comprising the steps of:depositing a first portion of medicine adjacent the superior turbinate;depositing a second portion of medicine adjacent the middle turbinate;and depositing a third portion medicine adjacent the inferior turbinate.3. The method of claim 2, wherein the first portion of medicine isdeposited in a targeted manner adjacent an anterior end of the superiorturbinate; wherein the second portion of medicine is deposited in atargeted manner adjacent an anterior end of the middle turbinate; andwherein the third portion of medicine is deposited in a targeted manneradjacent an anterior end of the inferior turbinate.
 4. The method ofclaim 2, the step of depositing the medicine, further comprising thestep of: depositing the medicine in a first phase state having a firstviscosity, wherein the medicine heats up within the nasal cavity andtransitions into a second phase state having a second viscosity, whereinsecond viscosity is lower than the first viscosity.
 5. The method ofclaim 4, further comprising the step of: effecting the transition of themedicine from the first phase state to the second phase state, such thatthe medicine flows to coat one of the superior, middle, and inferiorturbinate.
 6. The method of claim 5, wherein the transition of themedicine from the first phase state to the second phase state isaccomplished by melting, wherein the medicine has a melting point ofabout 90° F. to about 100° F.
 7. The method of claim 5, wherein themedicine is displaced via gravity from a first position adjacent ananterior aspect of a lateral wall defining a portion of the nasal cavityto a second position adjacent a nasal ostea posterior to the firstposition.
 8. The method of claim 5, wherein the medicine is anon-Newtonian fluid at the first phase state and wherein the medicine isa Newtonian fluid at the second phase state.
 9. The method of claim 5,prior to the step of depositing the medicine, further comprising thesteps of: inserting the medicine carried by a delivery device into thenasal cavity, a portion of the delivery device having an arcuateconfiguration complementary to a nasal cavity anterior wall; andejecting the medicine from the delivery device.
 10. The method of claim9, wherein the delivery device includes a proximal end and a distal end,and defines a lumen, and wherein prior to the step of depositing themedicine further comprises the steps of: inserting the distal end of thedelivery device through a nostril until the distal end of the deliverydevice is adjacent an anterior end of the superior turbinate; anddrawing the delivery device outward from the nasal cavity through thenostril while simultaneously ejecting the medicine through the lumen.11. The method of claim 5, prior to the step of depositing the medicine,further comprising the steps of: inserting the medicine through anostril, the medicine integrally formed in a self-supporting generallyrigid member.
 12. The method of claim 11, wherein the self-supportinggenerally rigid member has an arcuate configuration curved complementaryto a curvature of a nasal cavity anterior wall.
 13. The method of claim5, prior to the step of depositing the medicine, further comprising thestep of: inserting the medicine through a nostril, the medicineintegrally formed in a flexible linear suppository; and bending theflexible linear suppository, wherein the suppository is linear in anundelivered position outside the nasal cavity, and the suppository isarcuate in a delivered position inside the nasal cavity.
 14. The methodof claim 13, wherein the step of inserting a flexible linear suppositoryinto the nasal cavity is accomplished by rotating the suppository,wherein the suppository includes a plurality of helically extendingedges winding about a longitudinal axis of the suppository.
 15. Themethod of claim 1, wherein the superior and middle turbinate define afirst passageway therebetween, the middle and inferior turbinate definea second passageway therebetween, and the inferior turbinate and a floorof the nasal cavity define a third passageway therebetween, furthercomprising the step of: depositing the medicine adjacent one of thefirst, second, and third passageways.
 16. The method of claim 15,further comprising the steps of: depositing a first portion of themedicine adjacent the first passageway; depositing a second portion ofthe medicine adjacent the second passageway; and depositing a thirdportion of the medicine adjacent the third passageway.
 17. The method ofclaim 16, wherein the first portion of medicine is deposited in atargeted manner adjacent an anterior end of the first passageway;wherein the second portion of medicine is deposited in a targeted manneradjacent an anterior end of the second passageway; and wherein the thirdportion of medicine is deposited in a targeted manner adjacent ananterior end of the third passageway.
 18. The method of claim 17, thestep of depositing the medicine, further comprising the steps of:depositing a bead of medicine in a first phase state at a firstviscosity wherein the bead of medicine heats up within nasal cavity andtransitions into a second phase state at a second viscosity such thatthe medicine moves along one of the first, second, and thirdpassageways; and wherein the second viscosity is lower than the firstviscosity.
 19. The method of claim 1, wherein the medicine is in one of(i) a semi-solid state and (ii) a solid state, further comprising thestep of: moving the patient to a supine position, wherein the medicineheats up within nasal cavity and melts from either (i) the semi-solidstate and (ii) the solid state into a liquid and the medicine flowsposteriorly under gravitation force.
 20. A method comprising the stepsof: delivering medicine in a targeted manner to a position within anasal cavity, wherein the medicine is carried by one of the following:(i) a gel-based substance within a medication container configured to beejected through a lumen; (ii) a self-supporting generally rigid arcuatestructure curved complementary to a curvature of a nasal cavity anteriorwall; and (iii) a semi-flexible linear member including a plurality ofhelically extending edges winding about a longitudinal axis; and whereinthe medicine is delivered in a first phase state at a first viscosity,and then heats up when exposed to body temperature within the nasalcavity and transitions into a second phase state at a second viscositylower than the first viscosity such that the medicine flows to coat atleast a portion of a turbinate.